A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects with Moderate Renal Impairment and Acute Myocardial Infarction

CSL Behring LLC0 个研究点目标入组 81 人开始时间: 2017年1月4日最近更新: 2017年10月23日

适应症

试验速览

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•Men or women aged at least 18 years of age, with body weight 50 kg or more
•Evidence of moderate RI (estimated glomerular filtration rate [eGFR] = 30 and < 60 mL/min/1.73 m2) as calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation)
•Evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) AMI
•Documented evidence of stable hepatic and renal function and no clinical suspicion of acute kidney injury (AKI) at least 12 hours after the first medical contact for the index AMI.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 41

•Symptoms, biomarker elevation or electrocardiogram (ECG) changes other than those of the index event that are consistent with a diagnosis of AMI but are likely not due to primary myocardial ischemia
•Ongoing hemodynamic instability
•Planned coronary artery bypass surgery
•Evidence of hepatobiliary disease
•History of acute kidney injury (AKI) after previous exposure to an intravenous contrast agent.
•History of nephrotic range proteinuria.
•Known history of allergy to soy beans or peanuts, immunoglobulin A (IgA) deficiency, antibodies to IgA , or hypersensitivity to CSL112 or any of its components.
•Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study.

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